UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022227 |
|---|---|
| Receipt number | R000022145 |
| Scientific Title | Differences in biological responses between open and closed system cardiopulmonary bypass for adult cardiac surgery |
| Date of disclosure of the study information | 2016/05/09 |
| Last modified on | 2016/05/06 19:11:09 |
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Basic information
Public title
Differences in biological responses between open and closed system cardiopulmonary bypass for adult cardiac surgery
Acronym
Biological responses after usage of open and closed system cardiopulmonary bypass
Scientific Title
Differences in biological responses between open and closed system cardiopulmonary bypass for adult cardiac surgery
Scientific Title:Acronym
Biological responses after usage of open and closed system cardiopulmonary bypass
Region
| Japan |
Condition
Condition
valvular heart disease requiring valve replacement or valve plasty
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate differences in biological reactions between an opened-fashion and a closed-fashion cardiopulmonary bypass circuit system in adult patients who undergo cardiac valve surgery
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1. length of ICU stay
2. length of postoperative mechanical ventilation
Key secondary outcomes
1. postoperative WBC count
2. postoperaitve hemoglobin and hematocrit
3. postoperative serum creatinine
4. postoperative serum ASL/ALT
(1-4;maximum value within 2 days of surgery)
5. postoperative acute kidney injury (assessed with AKIN classification)
6. intraoperative bleeding
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
A total 24 patients consist of the study population. These 24 patients are prospectively divided into the CS-CPB group and OS-CPB group in double blind fashion. Then, the patients will undergo cardiac valve surgery using either open system or closed system cardiopulmonary bypass. Blood collection is performed at four time points, before starting CPB, immediately after surgery, and 24 and 48 hours after surgery. In each time point, the following data are measured; white blood cell, hemoglobin, hematocrit, platelet, serum creatinine, serum AST, serum ALT. Length of postoperative mechanical ventilation, ICU stay, occurrence of AKI, and intraoperative bleeding are investigated in each group.
Interventions/Control_2
A total 24 patients consist of the study population. These 24 patients are prospectively divided into the CS-CPB group and OS-CPB group in double blind fashion. Then, the patients will undergo cardiac valve surgery using either open system or closed system cardiopulmonary bypass. Blood collection is performed at four time points, before starting CPB, immediately after surgery, and 24 and 48 hours after surgery. In each time point, the following data are measured; white blood cell, hemoglobin, hematocrit, platelet, serum creatinine, serum AST, serum ALT. Length of postoperative mechanical ventilation, ICU stay, occurrence of AKI, and intraoperative bleeding are investigated in each group.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 50 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those who undergo elective cardiac valve surgery in the Saitama Medical Center, Jichi Medical University, Saitama, Japan
Key exclusion criteria
1) patients aged 49 years or younger
2) patients aged 76 years or older
3) patients who undergo surgical concomitant coronary artery revascularization or thoracic aortic surgery
4) patients who have preoperative liver dysfunction (AST > 30 IU/l and ALT > 30 IU/l)
5) patients who have chronic kidney diseae (serum creatinine level > 2.0mg/dl)
6) patients who have autoimmune disease
7) patients who are treated with steroid or other immune suppressing drug
8) patients who have blood disorder
9) patients in whom preoperative informed consent is difficult
10)patients who have decreased left ventricular function (left ventricular ejection fraction < 40%)
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | NAOYUKI KIMURA |
Organization
Saitama Medical Center, Jichi Medical University
Division name
Cardiovascular Surgery
Zip code
Address
1-847, Amanuma-cho, Omiya-ku, Saitama, 330-0834, Japan
TEL
+81-48-647-2111
kimura-n@omiya.jichi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoyuki Kimura |
Organization
Saitama Medical Center, Jichi Medical University
Division name
Cardiovascular Surgery
Zip code
Address
1-847, Amanuma-cho, Omiya-ku, Saitama, 330-0834, Japan
TEL
+81-48-647-2111
Homepage URL
kimura-n@omiya.jichi.ac.jp
Sponsor or person
Institute
Saitama Medical Center, Jichi Medical University, Department of Cardiovascular Surgery
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Saitama Medical Center, Jichi Medical University
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2014 | Year | 11 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 06 | Day |
Last modified on
| 2016 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022145
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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